believe very strongly in properly conducted medical research. Because of the responses to this off-label treatment that
we continue to see in our patients, we hope to initiate formal clinical trials in the near future to scientifically evaluate
this treatment as applied to several of the malignancies where we've seen best results. We are an independent medical
practice without government or industry funding, and so at the present time we are unable to have the very substantial financial
resources and personnel to initiate a formal research arm. We expect that in the near future collaborative
efforts and other developments will make this possible. (Some may notice that a preliminary research submission
with the National Institutes of Health was temporarily withdrawn at our own initiative. This is because IRB approval
will require significant resources not currently available to us.)
We wish to make sure potential patients
understand that the program offered is off-label treatment in a medical practice and not a formal clinical trial. Of
course, FDA regulations specifically allow off-label treatment and it is done routinely in cancer clinics across the
nation. While we continue to see very gratifying results in our patients, they do not constitute controlled clinical
data and we do not represent them as such. You can read more about our results by clicking on the "Results"
page on this web site. Furthermore, we adhere strictly to FDA regulations and voluntarily keep them informed of our
status and outcomes.
When formal clinical trials are instituted, one thing will not change. The care of our patients, including
those who don't qualify for clinical trials, will always be our highest priority and the only reason for the existence
of this clinic.
As of July 2013 we have achieved excellent response in our first veterinary patient, a dog with a large and symptomatic
colon cancer. (Please be assured that animals are never present at any time in our clinic, and also that our non-human
patients will always receive the specialized care they deserve from a qualified veterinary doctor.) We have reason to
expect that this treatment method may prove successful against a variety of cancers in other mammals, especially dogs and
horses, and we look forward to veterinary applications playing an important part in future research and in compassion for
animals and the humans who love them.
working on the next wave of treatment innovations -- further advances that can build upon this very unique treatment
technique once it has been properly evaluated and its effectiveness fully demonstrated in formal clinical trials. Even
though some of these things will take ten to fifteen years to become widely available, they're in active planning now and
we think they have exciting potential. Here's a glimpse at some of the work currently in development or active planning:
of cancers occurring primarily in children
- Combination of this technique with new agents which can interact with
other relevant ligands/receptors to restore specific immune system functions
- Oral/transmucosal interferon delivery,
which may reduce side effects and cost even further, simplify treatment, and allow its use in more places around the globe
to achieve more consistent delivery to brain tissues, thus allowing better treatment of primary brain tumors and metastatic
- Optimizing the combination of this treatment with traditional chemotherapy and other existing therapies where
appropriate, to define which cancers do best with that approach and what dosages and timing work best. We are especially
interested in beneficial agents which may be inexpensive, well tolerated with low toxicity, readily available, independent
of need for intensive technology and specialized facilities/equipment, and suitable for outpatient use.
- Precisely characterizing
the immunologic and cellular mechanisms involved, since understanding how the treatment works in the body may lead to improving
it further and designing other effective targeted approaches
- Pre-treatment with cancer antigen specific vaccines
sensible, and cost-efficient prevention regimens for individuals at high risk for certain cancers
The process involved in testing
and approving each new facet of treatment is necessarily meticulous for both scientific and ethical reasons, and that takes
time and hard work and resources. But we think the promise of better cancer treatments available to more people is worth
everything we can give it, and we also think it's pretty exciting.